Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

NCT06437964 | Active Not Recruiting

• 1 other identifier: 2024-0629
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Whether prophylactic antibiotics should be administered in the endoscopic secondary prevention of GVB or not is unclear. In this non-inferiority trial, we are aimed to evaluate whether prophylactic antibiotics are essential in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.

Conditions

Cirrhosis, Liver; Hypertension, Portal; Variceal Hemorrhage

Keywords

Gastroesophageal Variceal Bleeding; Endoscopic Secondary Prevention; Prophylactic Antibiotics

Outcome Measures

Primary Outcomes (1)

• Postoperative fever

  Have fever (\>37.5℃) in hospital afer the endoscopic operation

  From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.

Secondary Outcomes (3)

• Postoperative 4-week rebleeding

  Within 4 weeks since the endoscopic operation

• Additional use of antibiotics

  From the date of endoscopic operation (after the endoscopy) until the date of hospital discharge, assessed up to 7 days.

• Postoperative hospital stays

  From the date of endoscopic operation until the date of hospital discharge, assessed up to 7 days.

Study Arms (2)

Prophylactic antibiotics

ACTIVE COMPARATOR

Intravenous infusion of 1.0g-2.0g ceftriaxone before endoscopic therapy

Drug: Prophylactic Antibiotics

No prophylactic antibiotics

EXPERIMENTAL

No use of prophylactic antibiotics before endoscopic therapy

Other: No use of prophylactic antibiotics

Interventions

Prophylactic Antibiotics DRUG

Intravenous infusion of 1.0g-2.0g ceftriaxone before endoscopic therapy

Prophylactic antibiotics

No use of prophylactic antibiotics OTHER

In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation.

No prophylactic antibiotics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhotic patients having a history of gastroesophageal variceal bleeding are readmitted for endoscopic secondary prevention.

You may not qualify if:

• Age \<18, or ≥81.
• The patient is unwilling to sign the informed consent form.
• Allergy to cephalosporin.
• Have granulocyte deficiency (neutrophil count ≤ 0.5 \* 10 \^ 9/L, or white blood cell count ≤ 1.0 \* 10 \^ 9/L) before the endoscopic operation.
• Already have infection or fever (body temperature \> 37.5 ℃) before signing the informed consent form.
• Withdraw Criteria:
• The patient turned back after signing the consent, and before the endoscopic operation.
• Have fever (body temperature \> 37.5 ℃) after signing the consent, and before the endoscopic operation.
• Transferred to other department for additional treatment after the endoscopic operation (Surgical department for malignant tumor, Interventional radiology department for splenic embolism or transjugular intrahepatic portosystemic shunt, etc.).
• The patient suffered massive bleeding during the endoscopy, and cephalosporin was given immediately after being sent back to the ward.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meng Xue, PhD

  Second Affiliated Hospital, School of Medicine, ZhejiangUniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: May 25, 2024
• Primary Completion: January 15, 2026
• Study Completion: February 10, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)